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The European Medicines Agency (EMA) has confirmed that they have approved the Pfizer-BioNTech coronavirus vaccine, which means that vaccinations can begin in the coming days across the EU.
“I am pleased to announce that the EMA scientific committee met today and recommended a conditional marketing authorization in the EU for the vaccine developed by Pfizer and BioNTech,” said EMA chief Emer Cooke at a press conference in line this Monday afternoon.
The announcement comes after clinical trials involving 40,000 participants, and the EMA stated that the vaccine meets standards for safety, efficacy and quality.
They have also stated that “there is no evidence” that the Comirnaty vaccine developed by BioNTech and Pfizer does not protect against the new strain of Covid-19.
This has paved the way for the vaccine to be rolled out in 27 EU countries, including Ireland, for people aged 16 and over, with the vaccine already approved for use in the UK, Canada and the US.
However, the European Commission has yet to approve the decision before the vaccine can be implemented, which could start on December 27.
A decision from the EU Commission is expected tonight.
An official statement from the EMA says:
The EMA has recommended granting a conditional marketing authorization for the Comirnaty vaccine, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people aged 16 and over.
The scientific opinion of the EMA paves the way for the first marketing authorization of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations that this entails.
The EMA Committee for Human Medicines (CHMP) has completed its rigorous evaluation of Comirnaty and has concluded by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend an authorization of formal conditional marketing. This will provide a robust and controlled framework to support vaccination campaigns across the EU and protect EU citizens.
“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, clinicians, developers and trial volunteers, as well as many experts from all EU Member States.
“Our comprehensive evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets the necessary quality standards. However, our work does not stop here. We will continue to collect and analyze data on the safety and efficacy of this vaccine to protect people who get vaccinated in the EU. “
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